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The aim of this study is to evaluate the effect of fenofibrate versus curcumin on glycemic status, lipids profile, hs-CRP, sirtuin-1 and fetuin-A in type 2 diabetic patients who are taking glimepiride.
Method & Proposal Steps
1- Approval will be obtained from Research Ethics Committee of Faculty of Pharmacy, Damanhour University. 2- All participants agreed to take part in this clinical study and provide informed consent. 3- (60) Patients with DM type 2 who's taking Glimepiride will be enrolled from Internal Medicine Department, Tanta University Hospital. 4- Serum samples will be collected for measuring the biomarkers. 5- All enrolled patients will be mentioned as two groups; Group I are patients who will be prescribed glimepiride plus fenofibrate. Group II are patients who will be prescribed glimepiride plus curcumin. 6- All patients will be followed up during 3 months' period. 7- At the end of 3 months on the new regimen, steps 4 will be repeated. 8- Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results. 9- Measuring outcome: The primary outcome is the change of serum levels of the measured markers after 3 months and lipid profile. 10- Results, conclusion, discussion and recommendations will be given.
Methodology Serum levels of fetuin-A, and Sirtuin1 (SIRT1) will be measured ELISA. Lipid profile. Fasting Blood glucose and 2 hrs postprandial Blood Glucose. Hb A1C will be measured. BMI of the patients will be measured before and after the study. High sensitivity C-reactive protein (hs-CRP) will be measured.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I | Experimental | Glimepiride (4 mg) per Day |
|
| Group II | Experimental | Glimepiride (4 mg) plus Fenofibrate (160 mg) per Day |
|
| Group III | Experimental | Glimepiride (4 mg) plus Curcumin (1100 mg) With 5mg Black Pepper per Day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glimepiride Tablets | Drug | Glimepiride (4 mg) per Day |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| fetuin-A (mg/L) | human Fetuin A protein | three months |
| Sirtuin1 (SIRT1) (ng/ml) | human Sirtuin1 a Protein - Recombinant human SIRT1 protein | three months |
| Measure | Description | Time Frame |
|---|---|---|
| Total Cholesterol (mg/dl) | Total Cholesterol | Three Months |
| Triglyceride (mg/dl) | Triglyceride | Three Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rehab H Werida, Ass.Prof. | Damanhour University | Study Chair |
| Eman Nada, B. Pharm | Damanhour University | Principal Investigator |
| Haidy Abass, Ass.Prof. | Damanhour University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tanta University Hospital | Tanta | El-Gharbia | 31527 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28735818 | Result | Panahi Y, Khalili N, Sahebi E, Namazi S, Reiner Z, Majeed M, Sahebkar A. Curcuminoids modify lipid profile in type 2 diabetes mellitus: A randomized controlled trial. Complement Ther Med. 2017 Aug;33:1-5. doi: 10.1016/j.ctim.2017.05.006. Epub 2017 May 29. | |
| 31013312 | Result | Poolsup N, Suksomboon N, Kurnianta PDM, Deawjaroen K. Effects of curcumin on glycemic control and lipid profile in prediabetes and type 2 diabetes mellitus: A systematic review and meta-analysis. PLoS One. 2019 Apr 23;14(4):e0215840. doi: 10.1371/journal.pone.0215840. eCollection 2019. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C057619 | glimepiride |
| D011345 | Fenofibrate |
| D003474 | Curcumin |
| ID | Term |
|---|---|
| D058607 | Fibric Acids |
| D058610 | Isobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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Double Blind
| glimepiride plus fenofibrate | Drug | Glimepiride (4 mg) plus Fenofibrate (160 mg) per Day |
|
|
| glimepiride plus curcumin | Drug | Glimepiride (4 mg) plus Curcumin (1100 mg) With 5mg Black Pepper per Day |
|
|
|
| 26105582 | Result | Noureldein MH, Abd El-Razek RS, El-Hefnawy MH, El-Mesallamy HO. Fenofibrate reduces inflammation in obese patients with or without type 2 diabetes mellitus via sirtuin 1/fetuin A axis. Diabetes Res Clin Pract. 2015 Sep;109(3):513-20. doi: 10.1016/j.diabres.2015.05.043. Epub 2015 Jun 11. |
| 40481568 | Derived | Nada EM, El-Gharbawy NM, Abbas H, Werida RH. Effect of adding fenofibrate versus curcumin to glimepiride in patients with type 2 diabetes: a randomized controlled trial. BMC Pharmacol Toxicol. 2025 Jun 6;26(1):119. doi: 10.1186/s40360-025-00950-y. |
| D004700 | Endocrine System Diseases |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010647 | Phenyl Ethers |
| D004987 | Ethers |
| D001577 | Benzophenones |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010636 | Phenols |
| D007659 | Ketones |
| D036381 | Diarylheptanoids |
| D006536 | Heptanes |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D002396 | Catechols |